Medtronic Perfusion Systems — EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
⚠️ Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 24, 2026
Worldwide - US Nationwide distribution.
What's affected?
- Product
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
- Lot code
- 0232601501
Additional details
UDI-DI: 20763000135670, Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13,510 units.
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